University of California

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Preventive Controls and Microbial Safety

Trevor Suslow, Cooperative Extension Specialist, University of California, Davis

The final FDA rule-making under the Food Safety Modernization Act (FSMA) is very close to becoming a reality and moving towards ‘Implementation’ timelines. The Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food (aka Preventive Controls) rule are anticipated to be released in final form by the convening of the International Conference on Fresh Cut Produce. This major FSMA rule will cover both domestic and foreign fresh-cut processing facilities exporting to the U.S. The standards may also apply to other establishments that hold fresh-cut products, such as distribution centers. Two key provisions of the anticipated Preventive Controls final rule is that each facility develop and implement a written Food Safety Plan which covers their suppliers (for example, farms under the Produce Rule which do not have to have  a written plan) and includes documented validation and verification of all preventive and process controls. The elements of the Food Safety Plan must include: (i) identification of all hazards (biological, chemical, physical, and radiological) specific to each food at the facility, (ii) documented evaluation of which hazards are “reasonably likely to occur,” (iii) implementation of validated preventive controls for each “reasonably likely to occur” hazard, and (iv) specific monitoring, corrective actions, and verification activities for each preventive control. This presentation will summarize the key provisions of the final Preventive Controls and use the challenges of validation of wash water process controls and Environmental Monitoring Programs as examples of essential actions needed by supply-chain stakeholders for compliance expectations.

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